Technician - Process Quality Assurance Floor Support (Night Shift)
Eli Lilly and Company
2 months ago
On-site
Durham, NC
$18.02 - $38.61 USD yearly
Operations
Job Responsibilities:
- Adhere to safety rules and support HSE corporate and site goals to maintain a safe work environment.
- Ensure training is completed and remains in compliance.
- Communicate with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues.
- Ensure adherence to good documentation practices and compliance with applicable procedures for Operations and Support personnel.
- Advise Operations and support personnel on quality matters and drive the site Quality culture.
- Maintain regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs, and quality systems.
- Review and approve GMP documentation for daily operations (electronic batch record logs, paper logbooks, cleaning, and procedures vs. performance).
- Perform daily documented Quality Checks.
- Collect, inspect, and deliver samples to storage location and/or laboratory.
- Troubleshoot and provide QA systems support to reconcile issues in systems (SAP, laboratory LIMS “Darwin,” TrackWise/PMX).
- Participate in self-led inspections and support internal/external regulatory inspections.
- Work cross-functionally with all levels of the organization.
Basic Requirements:
- High School / GED minimum.
- Authorized to work in the United States full-time; Lilly will not sponsor visas/work authorization.
- Completion of Post Offer Exam or Completion of Work Simulation (if applicable).
- Ability to work overtime as requested.
Additional Preferences:
- Strong oral and written communication and interpersonal skills.
- Bachelor’s degree in a science, engineering, computer, or pharmaceutical-related field (preferred).
- Knowledge of pharmaceutical process and Quality Systems.
- Knowledge of inventory management and deviation systems (e.g., SAP, TrackWise).
- Experience with combination products/devices; US/EU regulations and notified bodies.
- Previous experience in GMP production environments.
- Facility/area start-up experience.
- Knowledge of Validation/Qualification activities.
- Decision-making and problem-solving skills.
- Strong attention to detail.
- Ability to work independently or as part of a team to resolve issues.
Additional Information:
- Night shift supporting a 24/7 operation; rotating 12-hour day schedule. Onboarding: 8 hours Monday–Friday day shift, then transition upon supervision approval.
- May work in various areas within DAP and Warehouse buildings (mobility considerations).
Compensation/Benefits:
- Anticipated wage: $18.02 - $38.61.
- Full-time employees may be eligible for a company bonus (depending on company/individual performance).
- Comprehensive benefits for eligible employees (e.g., 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits).
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Adhere to safety rules and support HSE corporate and site goals to maintain a safe work environment.
- Ensure training is completed and remains in compliance.
- Communicate with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues.
- Ensure adherence to good documentation practices and compliance with applicable procedures for Operations and Support personnel.
- Advise Operations and support personnel on quality matters and drive the site Quality culture.
- Maintain regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs, and quality systems.
- Review and approve GMP documentation for daily operations (electronic batch record logs, paper logbooks, cleaning, and procedures vs. performance).
- Perform daily documented Quality Checks.
- Collect, inspect, and deliver samples to storage location and/or laboratory.
- Troubleshoot and provide QA systems support to reconcile issues in systems (SAP, laboratory LIMS “Darwin,” TrackWise/PMX).
- Participate in self-led inspections and support internal/external regulatory inspections.
- Work cross-functionally with all levels of the organization.
Basic Requirements:
- High School / GED minimum.
- Authorized to work in the United States full-time; Lilly will not sponsor visas/work authorization.
- Completion of Post Offer Exam or Completion of Work Simulation (if applicable).
- Ability to work overtime as requested.
Additional Preferences:
- Strong oral and written communication and interpersonal skills.
- Bachelor’s degree in a science, engineering, computer, or pharmaceutical-related field (preferred).
- Knowledge of pharmaceutical process and Quality Systems.
- Knowledge of inventory management and deviation systems (e.g., SAP, TrackWise).
- Experience with combination products/devices; US/EU regulations and notified bodies.
- Previous experience in GMP production environments.
- Facility/area start-up experience.
- Knowledge of Validation/Qualification activities.
- Decision-making and problem-solving skills.
- Strong attention to detail.
- Ability to work independently or as part of a team to resolve issues.
Additional Information:
- Night shift supporting a 24/7 operation; rotating 12-hour day schedule. Onboarding: 8 hours Monday–Friday day shift, then transition upon supervision approval.
- May work in various areas within DAP and Warehouse buildings (mobility considerations).
Compensation/Benefits:
- Anticipated wage: $18.02 - $38.61.
- Full-time employees may be eligible for a company bonus (depending on company/individual performance).
- Comprehensive benefits for eligible employees (e.g., 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits).
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation